Lundbeck Completes Acquisition of Chelsea Therapeutics

NORTHERA™ (droxidopa) is expected to be available to patients in the
U.S. during the fall of this year

June 24, 2014 10:00 AM Eastern Time

DEERFIELD, Ill.--(EON: Enhanced Online News)--H. Lundbeck A/S (Lundbeck) today announced that it has completed its
acquisition of Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP)
(Chelsea) for USD 6.44 per share in cash and non-transferable contingent
value rights that may pay up to an additional USD 1.50 per share upon
achievement of certain sales milestones, in each case without interest
and subject to any required withholding of taxes. As a result of the
acquisition, Chelsea became a wholly-owned indirect subsidiary of
Lundbeck, and shares of Chelsea common stock will no longer be listed on
the NASDAQ Capital Market.

“Lundbeck’s team of physicians and research scientists will partner with
the neurology community to conduct further studies aimed at better
understanding the long-term use of NORTHERA.”

“The acquisition of Chelsea and its lead therapy NORTHERA is a perfect
fit for Lundbeck in the U.S., given our track record supporting people
living with central nervous system (CNS) disorders that are often
overlooked or misunderstood,” said Staffan Schüberg, president of
Lundbeck in the U.S. “Over the past five years, we’ve brought three
therapies to the U.S. for people living with rare neurological disorders
where there is a significant unmet need – not only for therapies – but
for education and resources. Similarly, with today’s announcement, we’re
ready to partner with healthcare professionals, advocacy groups and
families to support adults living with symptomatic neurogenic
orthostatic hypotension.”

Lundbeck expects to make NORTHERA available in the U.S. through
specialty pharmacies in the fall of 2014. NORTHERA was approved by the
U.S. Food and Drug Administration (FDA) in February 2014 and is
indicated for the treatment of orthostatic dizziness, lightheadedness,
or the “feeling that you are about to black out” in adult patients with
symptomatic neurogenic orthostatic hypotension caused by primary
autonomic failure (Parkinson's disease, multiple system atrophy, and
pure autonomic failure), dopamine beta-hydroxylase deficiency, and
non-diabetic autonomic neuropathy. Effectiveness beyond two weeks of
treatment has not been demonstrated. The continued effectiveness of
NORTHERA should be assessed periodically.1 Please see below
for Important Safety Information including NORTHERA’s boxed warning for
supine hypertension. Click here
for NORTHERA Prescribing Information on the FDA’s DailyMed website.

NOH is a chronic condition that is caused by an underlying neurogenic
disorder, such as Parkinson's disease, multiple system atrophy or pure
autonomic failure.2 Symptoms of NOH include dizziness,
lightheadedness, blurred vision, fatigue and fainting episodes when a
person assumes a standing position.2

“Our passion to bring NORTHERA to the U.S. has been fueled by the unmet
need among patients, pressing our sense of urgency throughout the
clinical development process,” said Joseph G. Oliveto, president & chief
executive officer of Chelsea Therapeutics. “We are thrilled that
Lundbeck will carry this passion forward, given the company’s track
record of bringing therapies to people with rare diseases, supporting
patient communities and investing in research, development and
education.”

The NORTHERA approval was granted under the FDA’s accelerated approval
program, which allows for conditional approval of a medicine that fills
a serious unmet medical need, provided additional confirmatory studies
are conducted.

“We applaud Chelsea’s expertise and diligence in securing FDA approval
of NORTHERA, and are eager to begin the next phase of the therapy’s
clinical development program,” said Torsten Madsen, chief medical
officer and vice president of U.S. Drug Development at Lundbeck.
“Lundbeck’s team of physicians and research scientists will partner with
the neurology community to conduct further studies aimed at better
understanding the long-term use of NORTHERA.”

Individuals with questions about NORTHERA can reach Lundbeck at
855-351-2879.

About symptomatic neurogenic orthostatic hypotension (NOH)

Symptomatic NOH is a chronic condition that is caused by an underlying
neurogenic disorder, such as Parkinson's disease, multiple system
atrophy or pure autonomic failure.2 Symptoms of NOH include
dizziness, lightheadedness, blurred vision, fatigue, and fainting
episodes when a person assumes a standing position.2 These
symptoms often impair activities that require standing or walking for
both short and long periods of time.2,3 NOH is commonly seen
in patients with Parkinson’s disease, multiple system atrophy or pure
autonomic failure.4

Important Safety Information

WARNING: SUPINE HYPERTENSION

Monitor supine blood pressure prior to and during treatment and more
frequently when increasing doses. Elevating the head of the bed lessens
the risk of supine hypertension, and blood pressure should be measured
in this position. If supine hypertension cannot be managed by elevation
of the head of the bed, reduce or discontinue NORTHERA.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Supine Hypertension: NORTHERA therapy may cause or exacerbate
supine hypertension in patients with NOH, which may increase
cardiovascular risk if not well-managed.

Hyperpyrexia and Confusion: Postmarketing cases of a symptom
complex resembling neuroleptic malignant syndrome (NMS) have been
reported in Japan with NORTHERA use. Observe patients carefully when
the dosage of NORTHERA is changed or when concomitant levodopa is
reduced abruptly or discontinued, especially if the patient is
receiving neuroleptics. NMS is an uncommon but life-threatening
syndrome characterized by fever or hyperthermia, muscle rigidity,
involuntary movements, altered consciousness, and mental status
changes. The early diagnosis of this condition is important for the
appropriate management of these patients.

Allergic Reactions: This product contains FD&C Yellow No. 5
(tartrazine), which may cause allergic-type reactions (including
bronchial asthma) in certain susceptible persons. Although the overall
incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general
population is low, it is frequently seen in patients who also have
aspirin hypersensitivity.

ADVERSE REACTIONS

The most common adverse reactions (greater than 5%) were headache,
dizziness, nausea, hypertension, and fatigue.

DRUG INTERACTIONS

Administering NORTHERA in combination with other agents that increase
blood pressure (e.g., norepinephrine, ephedrine, midodrine and
triptans) would be expected to increase the risk for supine
hypertension. Dopa-decarboxylase inhibitors may require dose
adjustments for NORTHERA.

USE IN SPECIFIC POPULATIONS

Clinical experience with NORTHERA in patients with severe renal
function impairment (GFR less than 30 mL/min) is limited. There are no
adequate and well-controlled trials of NORTHERA in pregnant women.
Women who are nursing should choose nursing or NORTHERA. The safety
and effectiveness of NORTHERA in pediatric patients have not been
established. No overall differences in safety or effectiveness were
observed between subjects aged 75 years and older and younger subjects
in clinical trials, but greater sensitivity of some older individuals
cannot be ruled out.

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical
company specialized in brain diseases. For more than 50 years, we have
been at the forefront of research within neuroscience. Our development
and distribution of pioneering treatments continue to make a difference
to people living with brain diseases. Our key areas of focus are alcohol
dependence, Alzheimer’s disease, depression/anxiety, epilepsy,
Huntington’s disease, Parkinson’s disease, schizophrenia and stroke.

Our approximately 6,000 employees in 57 countries are engaged in the
entire value chain throughout research, development, production,
marketing and sales, and are committed to improving the quality of life
of people living with brain diseases. Our pipeline consists of several
late-stage development programs and our products are available in more
than 100 countries. We have research centers in China, Denmark and the
United States, and production facilities in China, Denmark, France,
Italy and Mexico. Lundbeck generated revenue of DKK 15.3 billion in 2013
(EUR 2.0 billion; USD 2.7 billion).

Lundbeck’s shares are listed on the stock exchange in Copenhagen under
the symbol “LUN”. Lundbeck has a sponsored Level 1 ADR program listed in
the US (OTC) under the symbol “HLUYY”. For additional information, we
encourage you to visit our corporate site www.lundbeck.com.

About Lundbeck in the U.S.

Based in Deerfield, Ill., Lundbeck U.S. was formed in 2009 as a
wholly-owned subsidiary of H. Lundbeck A/S in Denmark. With a focus on
accelerating advances in brain disorders, employees are engaged in the
research, development, production, marketing and sale of innovative
therapies that fulfill unmet medical needs among people living with
challenging and sometimes rare neurologic and psychiatric disorders. In
its late-stage research pipeline, the company has neurology compounds
under investigation for Alzheimer’s disease, stroke and epilepsy, in
addition to therapies in development for mental health disorders. With a
special commitment to the lives of patients, families and caregivers,
Lundbeck actively engages in hundreds of initiatives each year that
support our patient communities. To learn more, visit us at www.LundbeckUS.com
and connect with us on Twitter at @LundbeckUS.

Safe Harbor/Forward-Looking Statements

The above information contains forward-looking statements that
provide our expectations or forecasts of future events such as new
product introductions, product approvals and financial performance.

Such forward-looking statements are subject to risks, uncertainties
and inaccurate assumptions. This may cause actual results to differ
materially from expectations and it may cause any or all of our
forward-looking statements here or in other publications to be wrong.
Factors that may affect future results include interest rate and
currency exchange rate fluctuations, delay or failure of development
projects, production problems, unexpected contract breaches or
terminations, government-mandated or market-driven price decreases for
Lundbeck's products, introduction of competing products, Lundbeck's
ability to successfully market both new and existing products, exposure
to product liability and other lawsuits, changes in reimbursement rules
and governmental laws and related interpretation thereof, unexpected
growth in costs and expenses, the possibility that the expected benefits
of the acquisition of Chelsea may not materialize as expected, the
impact of the current economic environment, fluctuations in operating
results, market acceptance of NORTHERA, and other risks that are
described in Chelsea’s Annual Report on Form 10-K for the year ended
December 31, 2013 and Chelsea’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2014. Lundbeck undertakes no obligation to
update these forward-looking statements except to the extent otherwise
required by law.

Certain assumptions made by Lundbeck are required by Danish
Securities Law for full disclosure of material corporate information.
Some assumptions, including assumptions relating to sales associated
with product that is prescribed for unapproved uses, are made taking
into account past performances of other similar drugs for similar
disease states or past performance of the same drug in other regions
where the product is currently marketed. It is important to note that
although physicians may, as part of their freedom to practice medicine
in the United States, prescribe approved drugs for any use they deem
appropriate, including unapproved uses, at Lundbeck, promotion of
unapproved uses is strictly prohibited.